朱慧玲 Email and Phone Number

1. Responsible for build up a new process or optimize the current process for clinical trial and the company to ensure the compliance of local regulations/laws and ICH-GCP.2. Work as an advisor to provide professional understanding in terms of GCP related compliance issues. Manage CAPA for clinical trials and company when audit or inspection comes.3. Provide training for whole operation team for new staff orientation, SOP training, and other class room training session. Help to develop… Show more 1. Responsible for build up a new process or optimize the current process for clinical trial and the company to ensure the compliance of local regulations/laws and ICH-GCP.2. Work as an advisor to provide professional understanding in terms of GCP related compliance issues. Manage CAPA for clinical trials and company when audit or inspection comes.3. Provide training for whole operation team for new staff orientation, SOP training, and other class room training session. Help to develop training materials for all training. 4. Provide support and work with regional team via participant some regional/global initiative to regarding training, process and compliance aspect. Show less

Work as a monitor mainly for oncology area in Roche and involved in clinical trial operation activities from investigational site start-up to close out. The main activities include initial EC submission and getting EC approval from site, site initiation visit, routine site monitoring remotely or in-field, maintaining relationship with investigaotrs during daily work, etc.

Quality & Compliance